A silver lining for Cipro victims

Ever since we sued the FDA for failing to respond to our August 2006 petition to increase warnings about the risk of tendon rupture with fluoroquinolone antibiotics, we’ve received a lot of valuable feedback from people who’ve had problems with these drugs, which include Cipro and Levaquin. Actually, “a lot” is a pretty big understatement: we’ve been downright flooded with the tales of drug-induced misfortune that have poured in through email, over the phone and by regular old snail-mail.

The good news? The FDA responded to our lawsuit by slapping fluoroquinolones with a black box warning – the strongest warning the FDA can request. The agency also required manufacturers to produce special Medication Guides that explain the risks and benefits of the drugs in language intended for patients.

The news we aren’t so happy about? The federal agency disagreed with the other essential part of our petition: that drugmakers should send physicians a Dear Doctor letter informing them of the side effects their patients might encounter with these drugs. But we are in it to win it, so we are now considering another lawsuit to force the FDA to require companies to send warning letters to doctors, since the agency has admitted that doctors are not adequately warned about these largely preventable tendon ruptures.

While we wait for the agency to see the light, I thought I’d try to answer one question that I’m sure is on the mind of everyone who has suffered tendinitis as a result of these drugs: When will I get better?

Unfortunately, there isn’t a clear, concrete answer to that question, but we do have some information that may be helpful.

A review of fluoroquinolone safety published in the Southern Medical Journal says “Even with early diagnosis and management, tendinitis heals slowly,” but also that “The mean recovery time reported is from 3 weeks for tendinitis to 3 months for a tendon rupture.”

The logical follow-up question is, of course, how do people recover from fluoroquinolone-induced tendon injuries?

Regrettably, there does not seem to be an easy answer to this question either — at this time there is no miracle cure that offers instantaneous relief to patients suffering from the symptoms of tendon damage.

But the Southern Medical Journal authors state that most patients can expect “complete recovery … if rupture is not present.” And while you wait for your body to heal itself, treatment is fairly intuitive: stop use of the fluoroquinolone and have your doctor switch you to another antibiotic; rest your tendons; use anti-inflammatory drugs for pain (being careful not to exceed daily limits); elevate your leg (if the pain is in your Achilles’ tendon); and ice the affected areas. Patients frequently use splints or crutches while they recover.

So the good news is that although some unlucky patients might require surgery, the odds are that, if you’ve been hurt by Cipro (or any of the fluoroquinolones, for that matter), you can probably expect your body to heal itself with “2 to 6 weeks of non-weight-bearing activity.” In other words: take a load off.
Anyone who experiences unexpected tendon pain while taking a fluoroquinolone antibiotic should stop taking the drug immediately, call their doctor and rest. For those of you who are interested in learning more about fluoroquinolone antibiotics – or any of the roughly 600 prescription and over-the-counter drugs our experts in drug safety have evaluated – can find out more by subscribing to www.WorstPills.org today.

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12 Responses

I fail to understand why another lawsuit would be required when the first lawsuit addressed the issues regarding the Dear Doctor Letter. Perhaps I am mistaken here but is not the first lawsuit still pending? Or has Public Citizen withdrawn that suit? Please don’t tell me that this ridiculous response from the FDA was found somehow to be adequate.

The Southern Journal article you are referring to is once again grossly mistaken and puts a ridiculous spin on these issues. It has been over eight years in my case and the tendonitis continues unabated. And I am far from the exception. These drugs are crippling people for life…a number of patients DO NOT heal in two to three weeks as claimed by this article. We are NOT recovering after two to six weeks of doing nothing either. Year after year we continue to be in misery and nothing the doctors do is of any value whatsoever. Any number of studies has shown this to be a persistent injury in some cases that does not respond to treatment.

That has to be the most outrageous statement made to date (recovering after two to six weeks) regarding these reactions. That and the number of reports being cited by the FDA. When is the medical community going to get it through their heads that the patient is at risk of being crippled for life?

A recent review of the MedWatch database, deleting the duplicate case report numbers, shows 468 ruptures with Levaquin alone, and an additional 171 for Cipro, being reported to the FDA. 639 reports total over the past twelve years, and this does not even include all of the other fluoroquinolones, let alone all of the reports made from 1962 (Nalidixic Acid, which was also associated with joint problems) to 1996, which were ALL excluded from MedWatch. Forty-four years worth. Nor does this include all the bizarre medical terms used to describe such a rupture and all of the different foreign names for the same drugs.

Sorry to be on such a negative rant here but this is infuriating. The advice to call your doctor is pointless. Just about every patient who does this is being told ‘it cannot be the drug’ and instructed to keep taking the medication. The NUMBER ONE complaint of those who suffer an adverse reaction to a fluoroquinolone drug is the fact that their doctors REFUSE to associate such reactions to this medication. Of over 400 patients responded to a survey on the fqresearch site and 99% of them indicated that their physicians knew NOTHING about these adverse drug reactions, and refused to believe that the drug could possibly be responsible for their problems.

The same goes for the advice to stop the medication when tendon pain presents. By then it is far too late. The damage has already been done; otherwise you would not be in pain. This is as frivolous as suggesting to close the barn door after the horses have run off. What possible good would come from that?

Already physicians have indicated that they have no intention of changing their prescribing habits as a result of this box being drawn around an existing warning. And the drug reps are spinning this as no big deal. The warning has always been there so this is nothing new in the least. Only problem is the fact that treating physicians don’t bother to take the time to even look at the package inserts, let alone read them.

And where might I ask are the Black Box warnings for all of the other horrendous, and even fatal side effects of this class? The list would not even fit in this comment box. FATAL Liver, Kidney and Heart damage, irreversible peripheral neuropathy, disfiguring rashes, toxic psychosis, the list just goes on and on and on.

Though the victims honestly appreciate Public Citizen’s efforts, this warning is a slap to the face as far as we are concerned. Far TOO LITTLE, far too late. It will be years before such warnings are even made available to the public, as the FDA did NOT mandate that these warnings be sent to all the pharmacies to replace the existing package inserts. All of the drugs in the pipeline will have to be exhausted first, as well as the stockpile of existing package inserts before these new warnings even see the light of day.

We are just now seeing the warnings that were added four years ago regarding
Peripheral Neuropathy (irreversible nerve damage), Heart Problems (prolonged QT Interval / Torsades de pointes), Pseudomembranous colitis, Rhabdomyolysis (muscle wasting), Steven Johnson Syndrome, as well as concurrent usage of NSAIDs contributing to the severity of these reactions.

Feb 14, 2008, Bayer was reported to be sending letters warning doctors in Europe regarding severe and even fatal liver reactions as well as SJS and TEN in patients taking its Avelox antibiotic. Perhaps you failed to notice, but there were no such letters sent here in the States and Bayer has indicated that they have no intention of doing so either.

We have waited two and one half decades and this all that the FDA is willing to do? Draw a box around a grossly inadequate and frivolous warning and then refuse to tell the treating physician that they have done so? And you had to sue them in Federal Court to even get them to do that? Thanks, but no thanks. NO where near adequate in the least. Again we state: “far too little, far too late…”

David,
All I can say is you have said a mouth full. You could not have said it any better. Those of us who ARE damaged by these drug’s it is a little to late for us.And you will if ever find a Dr to say the antibotic is the cause of ALL of the problem’s we are having. I was on Cipro for 6 year’s daily 500 mg . I am a kidney transplant reciepient and 6 year’s ago i went in the hospital and ended up in a coma for 5 1/2 week’s.
The Dr does not even know why.It could have been from the Cipro i had been on and off of in the year’s before. Or at the time I was in the hospital.But I do know I almost died from something. I am not on Cipro anymore .And the only reason I was on it is because my transplant Dr’s put me on it as a pervenative to help me from ever getting or as sick if I ever did. And I have been on Cipro 1000 mg a day at time’s when I was sick at home. There is a lot of people who this may not have effected and Thank God for that but the one’s of us that has been has a long hard road in front of and a painful one. If we evenmake it to the end of the road. It may be a dead end road…..

how about addressing my eleven years of hell ffrom levaquin!!! the tendons, tendonosis, peripheral neuropathy, neerve damage and i know plenty of people who have the brain toxicity…. i have been all over the u.s. and no one has any solutions!!! they say there is too much damage to operate…nice, huh??? if you had perisited in 8/1996 the petition to the fda, myself and thousands of others would not be in the shape we are in…. i thank god for my illinois state representative and the il attorney generals office for getting the ball rolling.(AGAIN)… i am still in contact with them, as is my illinois state rep is also…. fda has still not responded to the illinois atorney general’s petition of may 2005…. my BIG question to you… why did you not follow through with all of this in your first petition???? you could have saved thousands of people their quality of life…. even calls to you went un-answered…even after all the petitiones i have collected..(they are heart breaking) and trying to get a telephone call from you or and i even mentioned to your secretary i would fly to present to you all that i had of the VICTIMS of this class of drugs went un-answered…… at least my state rep and the illinois attorney general’s office listened to me and continue to do so and we are still working together on this….

sorry for the typo’s….. i was typing too fast and my blood as i am frustrated with you… i subscribe to your publications and now another suit???? i have a ton of material, but to be ignored by you is disgusting….

sorry for the typo’s….. i was typing too fast and i was seeing red as i am frustrated with you… i subscribe to your publications and now another suit???? i have a ton of material, but to be ignored by you is disgusting….

This is crazy. I can’t believe lawyers aren’t circeling like sharks. Thousands of people like me damaged for life. Doctors can’t help us if this huge problem is covered up. Thank god for the internet .

Now that it is October 1st, where are the black box warnings do I can call my physician and at least complain about feeling like a 120 years old bag of bones. Unfortunately for those sufferers like me, we will continue to stay wide awake all night because of Cipro induced insomnia, our ears will be constantly ringing, we will have panic attacks, suffer with the pain of peripheral neuropathy and a dozen other permanent side effects that never made it to a black box. And yes, all the doctors I have seen think I am a mental case. But we know it is the Cipro. Hardly a silver lining… We need public citizen to keep this in the press…Please help us at least retain our dignity if we can’t be cured and our pain cannot be relieved.

Finding an antidote for Cipro damages (our dog is practically crawling as a result of this treatment) is the action all should be puching. I spoke to both Schering-Plough and Bayer about this and they said no research is being done in their labs or anywhere that they know about! This, to me, is the most criminal of attitudes.

All credit to Public Citizen for forcing the FDA to take action, but the Dear Doctor letters are also needed. It is incorrect to for the Southern Medical Journal authors to state “complete recovery … if rupture is not present.” Once severe tendinitis has occurred the affected tendon is weakened for life, and it is significantly more likely to be re-injured in the future. I am not a medical professional, but I write as someone who has acute Achilles tendinitis in both legs (arising after a course of cipro), and can no longer ride a bicycle without re-injury.